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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Schering-Plough |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000658 |
To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL).
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin HIV Infections |
Drug: Bleomycin sulfate Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Allopurinol Drug: Methotrexate Drug: Cytarabine Drug: Leucovorin calcium Drug: Sargramostim Drug: Dexamethasone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 250 |
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.
Patients are randomized to one of two treatment groups. Patients are stratified for (1) presence or absence of a prior AIDS diagnosis, (2) Karnofsky performance status of 70 or greater and lower than 70. Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia. Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves. AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time.
PER AMENDMENT 5/30/95: This trial was closed to accrual on 11/7/94 on the recommendation of the Data and Safety Monitoring Board (DSMB), because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
ddI, except when patient is also taking allopurinol.
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S), pyrimethamine/sulfa, or ganciclovir.
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Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy as outlined in protocol.
Study Chair: | L Kaplan | |
Study Chair: | AA Levine | |
Study Chair: | DJ Straus |
Study ID Numbers: | ACTG 142 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000658 |
Health Authority: | United States: Federal Government |
M-BACOD protocol Granulocyte-Macrophage Colony-Stimulating Factor Acquired Immunodeficiency Syndrome Allopurinol Antineoplastic Agents, Combined |
Dexamethasone Sexually Transmitted Diseases, Viral Allopurinol Lymphoma, small cleaved-cell, diffuse Leucovorin Cyclophosphamide Methotrexate Retroviridae Infections Lymphoma Cytarabine Dexamethasone acetate Immunoproliferative Disorders Acquired Immunodeficiency Syndrome |
Vincristine Bleomycin Immunologic Deficiency Syndromes Doxorubicin Virus Diseases Folic Acid Lymphatic Diseases Calcium, Dietary HIV Infections Sexually Transmitted Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Anti-Inflammatory Agents Anti-Infective Agents Slow Virus Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Free Radical Scavengers Abortifacient Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immune System Diseases |
Antineoplastic Agents, Hormonal Abortifacient Agents, Nonsteroidal Glucocorticoids Neoplasms Antineoplastic Agents, Phytogenic Antimetabolites Antioxidants Immunologic Factors Antineoplastic Agents Reproductive Control Agents Antibiotics, Antineoplastic Infection Gout Suppressants Vitamins Micronutrients |